An acute leukemia treatment that withdrew its new drug application (NDA) and then was reapproved by the FDA in 2017 has now been approved in Korea. The drug is Pfizer’s ‘Mylotarg (gemtuzumab ozogamicin).’

On the 18th, the Ministry of Food and Drug Safety approved Prizer’s 'Mylotarg inj.4.5mg.’ The drug is indicated for the treatment of newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML).

The approval gained attention because it was the second time the company received approval for the drug after voluntarily withdrawing its treatment from the market.

Wyeth first received approval for Mylotarg in 2000. At the time, the drug r